Back to resultsBONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Placebo
ibandronate [Bonviva/Boniva]
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- postmenopausal women or men >30 years of age;
- osteoporosis;
- vertebral osteoporotic fracture in past 4 weeks;
- fracture-related pain requiring analgesic treatment.
Exclusion Criteria:
- non-menopausal women;
- current treatment with another bisphosphonate;
- current treatment with class III analgesics.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).
Secondary Outcome Measures
Percentage of patients with >=50% diminution of pain between day 0 and 7
Pain control
Analgesic medication
Hospitalization
AEs and laboratory parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00493623
Brief Title
BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.
Official Title
A Randomized, Double-blind Study of the Efficacy of Intravenous Bonviva in the Relief of Pain After Recent Vertebral Osteoporotic Fracture in Osteoporotic Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will assess the efficacy and safety of intravenous Bonviva in patients with osteoporosis experiencing pain after recent vertebral osteoporotic fracture. Patients will be randomized to receive either Bonviva (3mg i.v. bolus injection) or placebo. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo i.v. single dose
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
3mg i.v. single dose
Primary Outcome Measure Information:
Title
Success of Bonviva therapy (>=20% diminution of pain intensity between day 0 and 7, with stabilization or diminution of concomitant analgesics between day 3 and 7).
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Percentage of patients with >=50% diminution of pain between day 0 and 7
Time Frame
Day 7
Title
Pain control
Time Frame
Day 7 and 1 month
Title
Analgesic medication
Time Frame
1 month
Title
Hospitalization
Time Frame
1 month
Title
AEs and laboratory parameters
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
postmenopausal women or men >30 years of age;
osteoporosis;
vertebral osteoporotic fracture in past 4 weeks;
fracture-related pain requiring analgesic treatment.
Exclusion Criteria:
non-menopausal women;
current treatment with another bisphosphonate;
current treatment with class III analgesics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Aix En Provence
ZIP/Postal Code
13616
Country
France
City
Amiens
ZIP/Postal Code
80054
Country
France
City
Angers
ZIP/Postal Code
49033
Country
France
City
Bonneville
ZIP/Postal Code
74136
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Cannes
ZIP/Postal Code
06401
Country
France
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
City
Echirolles
ZIP/Postal Code
38434
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lomme
ZIP/Postal Code
59462
Country
France
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Mulhouse
ZIP/Postal Code
68070
Country
France
City
Nantes
ZIP/Postal Code
44035
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Orleans
ZIP/Postal Code
45000
Country
France
City
Paris
ZIP/Postal Code
75181
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75571
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Rennes
ZIP/Postal Code
35203
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Saint-priest En Jarez
ZIP/Postal Code
42277
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
BONDIR Study: A Study of Intravenous Bonviva (Ibandronate) After Recent Vertebral Osteoporotic Fracture in Patients With Osteoporosis.
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